Posted by SLS on June 18, 2005, at 11:12:53
Pregabalin (Lyrica) as Adjunctive Therapy for Partial Seizures in Adults With Epilepsy
On June 10, the FDA approved a new indication for pregabalin (Lyrica capsules, made by Pfizer, Inc.), allowing its use as adjunctive therapy for partial seizures in epileptic adults.
The approval was based on the results of three double-blind controlled trials in 1,052 patients, showing that the addition of pregabalin to an ongoing one- to three-drug standard regimen decreased the incidence of partial seizures by up to 51% in patients with inadequately controlled epilepsy.
Adverse events included dizziness, somnolence, dry mouth, peripheral edema, blurred vision, weight gain, and difficulty with concentration and attention. According to a company news release, the discontinuation rate due to adverse effects was low.
Pregabalin was previously approved by the FDA on Dec. 30, 2004, for the management of neuropathic pain associated with diabetic peripheral neuropathy and by the European Commission on July 6, 2004, for the treatment of peripheral neuropathic pain and as adjunctive therapy for partial seizures in adults with epilepsy.
poster:SLS
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URL: http://www.dr-bob.org/babble/20050617/msgs/514897.html